Kornimate/medical-research-clean huggingface dataset:
effect of yogurts supplemented with mobilee on joint function in healthy individuals with joint discomfort

Conditions: Low Intensity Knee Gonalgia

Summary: the purpose of this study is to determine whether the daily eating of a yogurt supplemented with mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia.

the prevalence of low intensity gonalgia is relatively high in western population. the purpose of the present intervention study is to determine whether the daily consumption of a yogurt supplemented with mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia. previous research using in vitro and animal models have demonstrated the efficacy of mobilee in reducing inflammation and promoting anabolic responses in joint tissues. in addition, in two previous human intervention trials, the effects of mobilee in joint function had been assessed using isokinetic tests. the present trial aims to confirm those previous results.

Eligibility criteria:
inclusion criteria: * adult (between 20 and 70 years of age) * subject with low intensity knee gonalgia (vas pain intensity between 3 and 5cm during at least the last 6 months) * healthy individual according to its medical records, physical and laboratorial parameters * positive informed consent exclusion criteria: * individuals requiring acetaminophen or any other drug to control pain * active rheumatoid arthritis or any other inflammatory joint disease * oral treatment with corticosteroids 4 weeks before selection * intra-articular treatment with corticosteroids 3 months before selection * significant injury of the study joint 12 months before selection * individuals receiving any drug or supplement for osteoarthritis * individuals requiring any type of medical prescription to control pain

Keywords: joint discomfort functional food joint function mobilee
s-ketamine prevents postoperative pain and cognitive dysfunction after tibial fracture

Conditions: Postoperative Pain; Postoperative Cognitive Dysfunction

Summary: purpose: to explore effects of s-ketamine on postoperative pain and cognitive dysfunction after tibial fracture and orthopedic surgery. to evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.

with the increase in human life span, orthopedic injuries and subsequent repair surgery have become a major health problem which impairs the life quality of patients and burdens healthcare systems worldwide. poor post-surgical pain control is a leading factor that hinders the physical rehabilitation and musculoskeletal functional recovery, and causes acute cognitive impairment and chronic pain syndrome. also, existing treatments of opioids and non-steroidal anti-inflammatory drugs have potential drawbacks, which may in turn interfere with bone healing. therefore, prophylaxis of fracture-associated pain is indispensable to postoperative comfort and satisfaction. there is no denying the fact that pathologic pain is related to central glutaminergic system and n-methyl-d-aspartate (nmda) receptor activation induced central sensitization. also, we previously reported that neuroinflammation is associated with pain development and cognitive dysfunction. ketamine, a nmda receptor antagonist, is effective in reversing nmda receptor activation underlying pain states. but the side effects of ketamine limit its clinical application, such as delirium, gibberish and agitation. it is clarified that s-ketamine has lower side effects than ketamine and that antinociception of s-ketamine is stronger than ketamine. the following study is carried out to evaluate whether s-ketamine can prevent postoperative pain and cognitive impairment after tibial fracture and orthopedic surgery in patients.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled to undergo tibial fracture with orthopedic surgery under a short general anesthesia of less than 2 hours 2. subject's american society of anesthesiologists physical status is i-ii. 3. the subject's parent/legally authorized guardian has given written informed consent to participate. exclusion criteria: 1. subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure. 2. subject has a diagnosis of insulin dependent diabetes. 3. subject is allergy and contraindication to s-ketamine. 4. subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids. 5. subject has any contraindication for the use of patient-controlled analgesia (pca). 6. subject is pregnant or breast-feeding. 7. subject is obese (body mass index \>30kg/m\^2). 8. subject is incapacity to comprehend pain assessment and cognitive assessment.

Keywords: s-ketamine tibial fracture orthopedic surgery pain intensity
effect of neoadjuvant radiation on tumor infiltrating t-cells by low dose radiation in colorectal liver metastases

Conditions: Colorectal Liver Metastases

Summary: the efficiency of t cell based immunotherapies is affected by the insufficient migration and activity of tumor specific effector t cells in the tumor. aim of this phase i/ii clinical trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve t cell connected anti tumor immune response in colorectal liver metastases. the primary endpoint is the number of tumor infiltrating t cells. furthermore the t cell activity in situ, the number of regulatory t cells and the frequency of tumor reactive t cells in the blood and bone marrow will be examined.


Eligibility criteria:
inclusion criteria: * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) * age ≥ 50 years * radiological urgently suspected colorectal liver metastasis exclusion criteria: * second malignancy * pregnancy and lactation * no prior liver radiation * liver metastasis must be resectable

Keywords: t cell surgery radiation
pharmaco-economical study in kidney transplantation

Conditions: Renal Transplant

Summary: the prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. however, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases ...). according to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. there is no recommendation in france to establish similar practices. ephegren is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.


Eligibility criteria:
inclusion criteria: * patients in the first month of renal graft, or patients already included in an other epidemiological french study (epigren) in the 0-6 month period * men of women aged more than 18 years * patients able to exercise in writing their informed and free consent to participate to the biological collection * patients not opposing to collect their medical data * patients registered with a social security system * patients able to complete the questionnaires exclusion criteria: * patients aged less than 18 years and patients under guardianship * patients with a follow-up at another center other than those part of the study

Keywords: cohort pharmaco-economic kidney transplantation quality of life
confocal laser endomicroscopy, ibs and stress

Conditions: Irritable Bowel Syndrome

Summary: after standard endomicroscopy with fluorescein to investigate for dysplasia in barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. fluorescein is needed for cle but is not part of the investigation. initial cle baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (iel) and epithelial breaks in the duodenal mucosa. thereafter, either 10 ml nacl 0.9% or 100µg crf topped up to 10ml with nacl 0.9% (according to randomisation) will be injected intravenously. endoscopist and assistant staff will be blinded to the randomisation. subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in iel, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space. post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ecp), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers. the procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. a study outline is presented in figure 1. samples taken are the same amount as done in the previous food associated study.


Eligibility criteria:
inclusion criteria: * age \>18 years * no abdominal symptoms such as bloating and abdominal pain * barrett's esophagus * independent indication for confocal laser endomicroscopy for evaluation of barrett's dysplasia * written informed consent for participation in this study exclusion criteria: * any known other gastrointestinal disease including infection such as helicobacter pylori, morbus whipple or others, celiac disease, or chronic inflammatory bowel disease * active or recent gi bleeding * stricture in the upper gastrointestinal tract * impaired renal function (creatinine \>1.2 mg/dl) * pregnancy or breast feeding * inability to obtain informed consent * known allergy to methylene blue or fluorescein * participation in other clinical trials within the last 4 weeks
biodistribution of neutrophile proteases in the sputum of patients affected by cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue. the respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results. the identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.


Eligibility criteria:
inclusion criteria: * man /woman older than 18 years (for adult and group) * child aged 6 to 18 years (for child group) * suffering from cystic fibrosis in stable condition, ie not having presented thrust acute attack of the broncho-pulmonary or hospitalization for treatment of his illness during the previous 2 weeks exclusion criteria: * colonized by burkholderia cepacia ou stenotrophomonas maltophilia * non smoker (control group) * without history or respiratory respiratory disease known (control group) * antibiotic treatment and / or anti-inflammatory drug (nsaid or corticosteroids) in the 2 weeks prior to the inclusion in the study (control group)
a study of scg101 in the treatment of subjects with hepatitis b virus-related hepatocellular carcinoma

Conditions: Hepatitis B Virus Related Hepatocellular Carcinoma; Hepatocellular Carcinoma Recurrent

Summary: this phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of scg101 in subjects with hepatitis b virus-related hepatocellular carcinoma

this study will be conducted in 2 parts: in phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of scg101. the recommended phase 2 dose (rp2d) will be selected based on the safety, pk/ pd and antitumor activities if the maximum tolerated dose (mtd) is not reached from the planned dose levels. in phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of scg101.

Eligibility criteria:
main inclusion criteria: * histologically or cytologically confirmed hepatocellular carcinoma (hcc) * subjects with hcc who have received at least 2 standard systemic therapies * hla-a \*02 * bclc stage b or c * child-pugh score ≤ 7 * serum hbeag negative, serum (or tumor tissue) hbsag positive, and serum hbv-dna must be 2 × 1000 iu/ml * have at least one measurable leasion at baseline as per mrecist and recist v1.1 criteria * life expectancy of 3 months or greater * ability to provide informed consent form * ability to comply with all the study procedures main exclusion criteria: * subjects with history of another primary cancer * untreated or active central nervous system (cns) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant cns diseases * autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection * known history of neurological or mental disorder, including epilepsy or dementia * known history of positive results for human immunodeficiency virus (hiv) 1 or 2 or known acquired immunodeficiency syndrome (aids) * prior exposure to any cell therapy such as, but not limited to killer (nk) cells, cytokine-induced killer (cik) cells, dendritic cells (dc), cytotoxic t lymphocytes (ctl), stem cell therapy, car t/tcr t cell therapy * allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine) * any subjects who cannot be evaluated by either triphasic liver ct or triphasic mri because of allergy or other contraindication to both ct and mri contrast agents * any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Keywords: hcc hepatitis b virus related hcc recurrent
application and effect evaluation of medium chain fatty acid rich milk powder in infants with cholestatic liver disease

Conditions: Cholestatic Liver Disease

Summary: to verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and to evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease.

this study will include all types of cholestatic liver disease in infants, randomized controlled study of the efficacy and safety of intervention with rich medium chain fatty acid milk powder,to verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease .

Eligibility criteria:
inclusion criteria: * meets the diagnostic criteria of cholestasis * artificial feeding (formula feeders) * age ≤6 months * the course of cholestasis was \> 1 month * informed consent of the guardian exclusion criteria: * there are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations * cholestasis with ascites and diarrhea * in patients with oxidative impairment of medium chain fatty acids
a long-term extension (lte) study of guselkumab in pediatric participants

Conditions: Crohns Disease; Colitis, Ulcerative; Arthritis, Psoriatic; Arthritis, Juvenile

Summary: the purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active crohn's disease, or juvenile psoriatic arthritis (jpsa).


Eligibility criteria:
inclusion criteria: * must have completed the dosing planned in the primary pediatric guselkumab study * must have received benefit from continued guselkumab therapy in the opinion of the investigator * before enrollment, a participant must be either: (a) not of childbearing potential, or (b) of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure * parent(s) (or their legally acceptable representative) must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. an adolescent who provides assent will have the opportunity to sign an adult icf upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate. exclusion criteria: * participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication * participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication * are pregnant, nursing, or planning pregnancy or fathering a child * have taken any disallowed therapies before the planned first long-term extension (lte) dose of study intervention * employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
genetic risks for bicuspid aortic valve disease

Conditions: Bicuspid Aortic Valve; Unicuspid Aortic Valve

Summary: bicuspid aortic valve (bav) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes. currently, it is estimated that most cases of aortic stenosis in patients less than 65 years old are caused by bavs. bav patients are also at high risk to develop aneurysms of the ascending aorta, which may lead to aortic dissections. dr. prakash and his colleagues plan to use individual genetic information to identify persons with bav who are at high risk for complications and to customize therapies.

to be included in the study, patients must have a bicuspid or unicuspid aortic valve, documented by clinical history or imaging studies. if the aortic valve was replaced surgically, they may still be eligible. participants will be asked to donate a single tube of blood and fill out a questionnaire. patients will also be followed up by telephone or email about once a year to determine if they experience any medical complications related to bicuspid aortic valve (bav), such as aortic aneurysms, aortic dissections or valve disease. patients may not be included if they are less than 18 years old at the time of recruitment or have a recognized genetic syndrome or genetic mutation such as marfan or ehlers-danlos syndrome.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosis of bicuspid or unicuspid aortic valve exclusion criteria: * less than 18 years of age * recognized syndrome or identified genetic mutation
wearable sensors and video recordings to monitor motor development

Conditions: Motor Delay; Neurodevelopmental Disorders; Developmental Disability

Summary: the objective of this study is to develop an automated, precise, quantitative assay for detecting atypical motor behavior and development in infants using data from wearable sensors and video recordings.


Eligibility criteria:
inclusion criteria: * individuals identified as potentially at risk of abnormal motor development due to a risk factor (for example, prematurity, neonatal hypoxic ischemic encephalopathy, or neonatal stroke) or control individuals for whom normal motor development is expected. * age: \< 24 months of age * legal guardian able and willing to give written consent and comply with study procedures. * in case of multiple pregnancies, only one child selected at random will participate in the research activities. study staff will have no influence over the selection, besides any known medical condition automatically excluding the baby as listed in our exclusion criteria. exclusion criteria: * any open wound or skin breakdown on the limbs or upper torso. * missing or incomplete limbs (such as from amputation or congenital limb defects) * legal guardian unable to give written consent and comply with study procedures.

Keywords: early detection wearable sensors computer vision
gamete treatment to correct fertilization failure

Conditions: Infertility

Summary: in this proposed research study, the investigators plan to assess the efficacy of gametes' (egg and sperm) treatment on fertilization as well as pre- and post-implantation embryo development.

the spermatozoa will be prepared in the standard fashion and utilized for injection after exposure to a membrane permeabilizing agent. the raw sperm specimen may be selected through a synthetic, sterile, single-use, culture-tested mesh. the specimen will then be placed in a 37°c environment. after 30 minutes, the selected portion is retrieved from the other side of the mesh. the spermatozoa will be prepared in the standard fashion will be utilized for injection or intrauterine insemination. human recombinant plc-zeta will also be used if the spermatozoa have been confirmed to be plc-zeta deficient. the injected oocytes will be then exposed to the previously mentioned activating agents for the purpose of inducing embryo development. the successfully fertilized oocytes will be further kept in culture for up to 5 days as per standard ivf/icsi. results in terms of fertilization and embryo cleavage will be assessed and monitored for the remainder of the culture period. developing embryos selected according to standard criteria will be replaced to the patient or will be cryopreserved. because fertilization failure carries such a high emotional and financial toll on our patients, at the present time, the only method to generate an embryo for these cases is to perform assisted oocyte activation in conjunction with icsi. the research intervention - assisted oocyte activation - is believed to help alleviate the failed fertilization by obtaining some zygotes for the patient. in these cases of complete failed fertilization, intracytoplasmic sperm injection (icsi) will be performed as a routine clinical treatment even if they are not enrolled in the study. after several failures, their reproductive physician may recommend the use of donor spermatozoa instead of the male partner's.

Eligibility criteria:
inclusion criteria: * patients with complete fertilization failure with standard ivf or failure with one prior icsi treatment cycle exclusion criteria: * not meeting inclusion criteria * ivf without icsi

Keywords: gamete treatment icsi ivf infertility oocyte activation